User Manual

2. INTENDED USE AND TARGETED POPULATION
INTENDED USE
The ALIZEA pacemakers are intended to stimulate the bradycardic patient’s heart with
electrical impulses as indicated in the guidelines on cardiac pacing
(1)
in order to maintain
or restore a normal heartbeat. SR devices are implantable single chamber pacemakers that
must be used with one lead (right atrial or ventricular lead). DR devices are implantable dual
chamber pacemakers that must be used with two leads (right atrial and ventricular leads).
(1)
Guidelines on cardiac pacing are provided by the European Society of Cardiology, the
American College of Cardiology and the American Heart Association ("2013 ESC Guidelines
on cardiac pacing and cardiac resynchronization therapy". Eur Heart J 2013;34:2281–2329,
“2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of
Cardiac Rhythm Abnormalities”. J Am Coll Cardiol. 2013; 61(3):e6-75).
INDICATIONS AND TARGETED POPULATION
SR and DR pacemakers treat all types of bradycardia and are respectively indicated for atrial
or ventricular pacing and synchronous atrio-Ventricular pacing as described below.
According to the guidelines, ALIZEA DR pacemakers are mainly indicated for the
following conditions:
― Accepted patient conditions warranting chronic cardiac pacing which include:
― symptomatic paroxysmal or permanent second- or third-degree AV block;
― symptomatic bilateral bundle branch block;
― symptomatic paroxysmal or transient sinus node dysfunctions with or without
associated AV conduction disorders;
― bradycardia-tachycardia syndrome to prevent symptomatic Bradycardia or some
forms of symptomatic tachyarrhythmias;
― vasovagal syndromes or hypersensitive carotid sinus syndromes.
― Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent
with increases in minute ventilation and/or activity.
― The ALIZEA DR are also indicated for dual-chamber and atrial tracking modes in
patients who may benefit from maintenance of AV synchrony. Dual-chamber modes are
specifically indicated for treatment of conduction disorders that require restoration of both
rate and AV synchrony which include:
― various degrees of AV block to maintain the atrial contribution to cardiac output;
― VVI intolerance (e.g. pacemaker syndrome) in the presence of persistent sinus
rhythm.
According to the guidelines, ALIZEA SR pacemakers are mainly indicated for the
following conditions:
― Accepted patient conditions warranting chronic cardiac pacing which include:
― symptomatic paroxysmal or permanent second- or third-degree AV block;
― symptomatic bilateral bundle branch block;
2.1.
2.2.
2. INTENDED USE AND TARGETED POPULATION
ALIZEA – UA10414A 11